Health Product Insights Report: July 2024 Edition

Contents

Monthly Summary of Health Product Safety Information

This article highlights the health product advisories, Type I drug recalls, and summaries of concluded safety reviews issued by Health Canada during June 2024.

Accel-Ondansetron ODT, Mint-Betahistine, and PMS-Pirfenidone

All lots of Accel-Ondansetron ODT (4 mg and 8 mg), Mint-Betahistine (8 mg, 16 mg, and 24 mg), and PMS-Pirfenidone (267 mg and 801 mg) tablets have been recalled over issues regarding the validation tests that ensure the functionality of these generic medications compared to their brand-name counterparts. At the request of Health Canada, the companies have halted sales until they can provide further evidence confirming the safety and efficacy of the products.

Albrioza (sodium phenylbutyrate and ursodoxicoltaurine)

Albrioza was granted authorization in 2022 under the Notice of Compliance with conditions policy for treating amyotrophic lateral sclerosis (ALS), based on Phase 2 clinical study results. However, as the Phase 3 confirmatory study failed to achieve its primary or secondary endpoints, Amylyx Pharmaceuticals, Inc. plans to withdraw Albrioza from the Canadian market by December 31, 2024. New patients should not start treatment with Albrioza. For existing patients, the medication is available exclusively through the Patient Support Program provided by Amylyx Pharmaceuticals, Inc.

Health Product Risk Communication: Albrioza (sodium phenylbutyrate and ursodoxicoltaurine)

Carbamazepine Extended-Release Tablets

Due to a shortage of carbamazepine extended-release tablets in Canada, Health Canada has authorized the temporary, exceptional importation and sale of Carbamazepine Extended-Release Tablets, USP, from the USA with English-only labels, recognizing the medical necessity of this anticonvulsant. It’s noted that there are differences in the formulation and appearance between the Canadian and USA-authorized products.

Health Product Risk Communication: Carbamazepine extended-release tablets

Dianeal PD4 2.5% Dextrose and Physioneal 40 2.27% Glucose Peritoneal Dialysis Solutions

Select lots of Dianeal and Physioneal dialysis solutions were recalled due to potential leaks at the connection site. The recalled lots were distributed in Canada between March 6, 2024, and May 29, 2024.

Isotretinoin

A safety review was conducted to assess the risk of sexual dysfunction associated with isotretinoin-containing products, including the potential for persistent dysfunction following discontinuation. Health Canada’s findings suggest that a connection cannot be entirely excluded. The agency is cooperating with manufacturers to update the Canadian product monograph for isotretinoin products and will take action to inform patients about this potential risk.

Safety Summary Review: Isotretinoin

JAMP Digoxin

One lot of JAMP Digoxin 0.0625 mg tablets has been recalled by JAMP Pharma Corporation due to the possibility that oversized tablets might be included in the lot.

Type 1 Drug Recall: JAMP Digoxin

Ratio-Ectosone (TEVA-Ectosone) 0.05% Mild Lotion

Teva Canada Ltd. announced the recall of one lot of ratio-Ectosone (TEVA-Ectosone) 0.05% mild lotion in 60 mL bottles after testing revealed an impurity, betamethasone enol aldehyde, exceeding the allowable limit in the affected lot.

Unauthorized Health Products

Health Canada cautioned the public about numerous unauthorized health products available for sale at retail locations across Canada or online, which may present serious health risks.

New Health Product Safety Information

This section highlights crucial information aimed at raising awareness and prompting reports of adverse reactions.

Product Monograph Update

The following safety labeling update has been added to the single ingredient monograph to inform stakeholders. Canadian single ingredient monographs for Natural Health Products are accessible through Health Canada’s Natural Health Products Ingredients Database.

Chaste Tree (Vitex agnus-castus)

The Contraindications section for Chaste tree (Vitex agnus-castus) in Health Canada’s monograph for oral administration has been revised.

Scope

This monthly newsletter is aimed at healthcare professionals and presents information regarding pharmaceuticals, biologics, medical devices, and natural health products. It summarizes significant health product safety information published in the prior month by Health Canada and highlights a selection of new relevant information meant to enhance awareness. The new content in this release is not exhaustive but emphasizes key clinical issues deserving wider communication.

Reporting Adverse Reactions

Canada Vigilance Program
Telephone: 1-866-234-2345
Fax or mail: Form accessible on MedEffect Canada

For detailed instructions on reporting adverse reactions, please visit the Adverse Reaction and Medical Device Problem Reporting page.

Useful Links

Contact Us

Your feedback is valuable. Please share your thoughts by reaching us at:
infowatch-infovigilance@hc-sc.gc.ca

Health Product InfoWatch Editorial Team
Marketed Health Products Directorate
Health Canada
Address Locator 1906C
Ottawa ON K1A 0K9

References